REMS For Mavacamten Could Involve Additional Monitoring, BMS Says
User Fee Delayed; Potential For Systolic Dysfunction Needs Watching
Executive Summary
The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters.
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Bristol already is training cardiologists at major treatment centers in how to treat obstructive hypertrophic cardiomyopathy with Camzyos (mavacamten) based on the REMS in the US label.
Cardiology Could Get A Jolt As FDA Reviews Novel Heart Failure Candidates From BMS, Cytokinetics
Upcoming US FDA decisions could bring breakthrough-designated approvals for BI/Lilly’s Jardiance in heart failure with preserved ejection fraction and BMS’ mavacamten in hypertrophic cardiomyopathy, while Cytokinetics bids to bring a new mechanism the busy heart failure with reduced ejection fraction space and earns a BTD in HCM.
Cytokinetics’ CK-274 Appears To Upstage BMS’s Newly Acquired Mavacamten
The REDWOOD-HCM study showed early, sustained efficacy and no serious adverse events with a drug Cytokinetics designed to be superior to mavacamten, a drug it spun out via BMS-acquired MyoKardia.